Head and Neck Cancer Clinical Trial
Official title:
Evaluation of the Combination of Docetaxel (Taxotere)/ Carboplatin in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of docetaxel plus carboplatin in treating
patients who have metastatic or recurrent head and neck cancer.
OBJECTIVES: I. Assess the survival of patients with metastatic or recurrent squamous cell
carcinoma of the head and neck receiving docetaxel and carboplatin. II. Assess time to
treatment failure and response rate (unconfirmed and confirmed complete and partial
response) in this patient population. III. Evaluate the toxicities of this regimen in this
patient population.
OUTLINE: Patients receive docetaxel IV over 1 hour immediately followed by carboplatin IV
over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of unacceptable
toxicity or disease progression. Patients are followed every 3 months for 1 year, every 6
months for 2 years, then annually thereafter until death.
PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study over 18 months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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